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Completed

NCT Number: NCT02775682

Cerebral Autoregulation in Patients With Epilepsy

The purpose of this study is to determine whether patients with epilepsy exhibiting impaired dCA, which may contribute to subsequent stroke.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

First Hospital of Jilin University

Changchun, Jilin, 130000, China

About this study

The relationship between epileptic seizures and cerebrovascular disease is complex, ranging from mechanisms to clinical manifestation. Stroke is one of the most common causes of epilepsy in adulthood. It was also reported that patients with epilepsy exhibited a higher risk of stroke. But its potential mechanism was never fully understood. Dynamic cerebral autoregulation(dCA), a mechanism to maintain the cerebral bold flow, has been proved to be critical for the occurrence ,development and prognosis of ischemic neurovascular disease. In this study, we hypothesis that impaired dCA play a role in epilepsy and subsequent stroke.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with epilepsy, as diagnosed by EEG

Exclusion criteria

  • patients with status epilepticus
  • intracranial and/or extracranial major vascular stenosis/occlusion diagnosed by a transcranial Doppler (EMS-9PB, Delica, China) and carotid ultrasound (IU22, Phillips, Andover, MA)
  • a prior symptomatic cerebral vascular disease
  • a history of hypertension, cardiovascular disease, diabetes, hyperlipemia, current arrhythmia, hyperthyroidism, anemia and unstable blood pressure, which may undermine hemodynamic stability, or inability to cooperate sufficiently to complete the cerebral auto regulation examination
  • insufficient bilateral temporal bone windows for insonation of the middle cerebral artery
  • intolerance to cerebral autoregulation measurements

Treatment and study plan

Primary outcomes

  1. phase difference(PD) in degree

    Time frame: 1 year

    A dynamic cerebral auto-regulation parameter derived from transfer function analysis.Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameters.

Secondary outcomes

  1. the rate of recovery of cerebral blood flow velocity

    Time frame: 1 year

    A dynamic cerebral auto-regulation parameter derived from transfer function analysis.The details are same as primary outcome

  2. gain in cm/s/mmHg

    Time frame: 1 year

    A dynamic cerebral auto-regulation parameter derived from transfer function analysis.The details are same as primary outcome

  3. the consequence of electroencephalograph（EEG）

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Yi Yang

Other

Registry information

Acronym: CAPE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 18, 2016
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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